Development of Alogliptin Oral-Dissolving Films with Optimized Therapeutic Outcomes.

Abstract

Introduction: The work aims at formulating Alogliptin benzoate as fast-dissolving film to bypass first-pass metabolism to improve therapeutic benefits.

Methods: Alogliptin Oral dissolving films (ODFs) prepared by solvent casting method and physico-chemically characterised. The in vitro dissolution was performed in pH 6.8 phosphate buffer. Accelerated stability studies were conducted.The antidiabetic activity of ODFs was assessed in diabetes-induced Wistar albino rats.

Results: The films were found to be slightly translucent, uniform, smooth and flexible in nature. The average weights were found to be 57.87 ± 4.59 mg. Optimized ODFs showed uniformity in drug content of 98.84 ± 2.22% while surface pH was found between 6.87 to 6.93. The FTIR analysis indicated no significant changes in the functional groups of Alogliptin benzoate in optimised formulation. The optimized Alogliptin benzoate ODF formulation shows altered thermal stability and retains the crystalline structure of the drug. Its rod-like crystals and formulation components enhance dissolution, enabling a rapid initial release. While the pure drug dissolves faster initially, ODF demonstrates efficient oral mucosa permeation and quicker blood glucose reduction within the first hour. The drug content in the formulation does not show any significant lowering (98.84 ± 2.22 initial and 96.89 ± 2.12 after 3 month of stability studies).Despite slightly lower glucose levels at 24 h, the ODF F formulation offers improved therapeutic efficiency and controlled release, making it effective for blood glucose management.

Conclusion: The Alogliptin benzoate ODF offers a promising alternative for diabetes management, providing rapid onset and improved patient compliance through easier administration.